Course Description

In June 2006 the EU implemented a change to Chapter 6 of the EU GMP Guide to add the requirement that the stability of marketed products be monitored according to a continuous programme that will detect any stability issues. ICH Q7 GMP for APIs also requires that “at least one batch per year of API manufactured should be added to the stability monitoring programme and tested annually to confirm stability”. This pharmaceutical training course is designed to help you understand and meet the EU GMP expectations in an effective and efficient manner that will add value to your business. You will receive detailed guidance on what is required for a compliant ongoing stability programme and how to analyse the data that is produced.

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